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shriphani writes "A US judge has ruled that Myriad Genetics' breast cancer gene patent is invalid. Hopefully this will go a long way in ensuring that patents on genes do not stand in the way of research. From the article: 'Patents on genes associated with hereditary breast and ovarian cancer are invalid, ruled a New York federal court today. The precedent-setting ruling marks the first time a court has found patents on genes unlawful and calls into question the validity of patents now held on approximately 2,000 human genes.'"

You can do all the research you like, it won't save lives. You can figure out how to make a drug that will cure [insert undesirable disease here] and publish the formula on the Internet.. watch as no-one will pay for the clinical trials to make the drug legal to sell.

So instead of a race to mass produce the unpatentable drug you have a race to produce the drug for the unpatentable gene. Whatever machinery you want to use to create the situation, the cost of clinical trials means drug companies need exclusivity from lab to drug store. The alternative is nationalized drug creation.. not that there's anything wrong with that, but know where your argument is going.. as the trials have become too expensive to expect drug companies to do in a race.

You can still patent the vaccine for polio (which the inventor could have patented and declined to because he thought it should be free), but you can't patent the genetic sequence of it. You can patent any treatment for breast cancer you want. However, patenting a discovery about a gene linked to breast cancer can't be done. There's nothing at all in this ruling that would jeopardize any actual or potential treatment or cure. The patent was to block research so no one could treat the "disease" as if someone patented polio was was suing anyone else working on a cure for polio.

Yes, I am. I understand that the patent system only patents creations and not discoveries. That makes me ignorant.

Ok, I'm a researcher, I want to find out the genetic cause of some untreatable disease.. because I want the disease to be treated. Who's going to pay for my lab time?

You either look out there for those who have posted requests for researchers and do what they ask, or you write proposals. Duh, now who's ignorant?

Previously, I could go to industry and say "ok, here's my credentials, you get the patents, deal?" and that's where the funding could come from.

Ah, so you are a whore who sells his soul for profit. And you blame people like me for getting in the way of you selling yourself for profit. You do all the work, they get all the rewards, and the two of you lock out everyone else. And, once the patent on the discovery is obtained, they use it to *prevent* a cure for profit for themselves at the cost of lives. And you like that system because it's easier for you to make money in that system.

No drug companies target the genes I discovered for treatments. After all, that'd start a race and no drug company can afford to get into a race.

So, making the first drug and patenting it to block others would make them billions, but they won't try because they would spend money and someone else might come up with something first? So, 400 years later, when the gene is known for hundreds of years and no one has started making a drug to fight it, do you think that one of them might try? No, they'll still be paralyzed because they think someone else might do it at the same time? Yup, that's consistent with your logic so far. After all, since the swine flu was well known, no one tried to make a vaccine for it. Or polio. Or HPV. Nope, those are well known viruses, so no one would ever waste money trying to cure those because someone else might also come up with a cure.

well they'll be poor drug companies in a few years when their current patents run out then.

No drug companies target the genes I discovered for treatments. After all, that'd start a race and no drug company can afford to get into a race.

Really?Drug companies aren't interested in potentially lucrative drug patents?By that logic they'd never fund your research to find the genetic cause of some untreatable disease since they'd be in a race with other companies to locate those genes and patent them.Which is complete bullshit.

Drug companies are always in a race, this just moves the starting line a little further along and allows more people take part.

Gene patents were always dubious to me, however patents on gene detection methods and kits should be fully capable of obtaining patent protection. It's like copyrights on facts vs collections.

I agree. How can you patent something that already exists? It would be like discovering some previously unknown roach and slapping a patent on it. Could you charge everyone whose home gets infested by these things? It's not like you invented it. You simply found it. Genes are in every single cell in our body. You can't patent them.

Now if you were to discover a gene sequence that does not naturally occur in nature... patent away. That might be pretty cool.

Evil thought: How about e turn it around. If I claim ownership of a dog, and that dog bites someone, I am liable for the medical bills.

If a biotech firm claims ownership of a gene and that gene causes cancer, they should be liable for the cancer. Perhaps they would be better off with a narrow patent on a particular method of screening for that gene's presence.

I think the problem is that the hard part is finding the sequence. Once you know the sequence, there's tons of systems in place that can detect it. It's like spending a million dollars to find a number.

Making a test that can cheaply identify a specific gene sequence is still a major goal of biotech firms. Today to get a screening for a handful of known cancer and heart disease risks cost over $1,200, much too expensive to be a routine test for the majority of health insurance customers. Drop that cost by 10x and suddenly you have a much larger market.

The device or a novel process? Yes. But you should not be able to patent the gene which effectively makes your device the only way to detect the disease. That is not what the patent system is for. It is for protecting novel inventions, not for locking up essential, basic knowledge with a toll booth.

The real issue, in my opinion, with these patents is that Myriad tries to make the information of the gene sequence essential to any detection method for that gene. Take a look at Myriad's patent [freepatentsonline.com] for the breast cancer-related gene BRCA2. Right at the beginning, "Specifically, the present invention relates to methods and materials used to isolate and detect a human breast cancer predisposing gene (BRCA2), some mutant alleles of which cause susceptibility to cancer, in particular breast cancer. More specifically, the invention relates to germline mutations in the BRCA2 gene and their use in the diagnosis of predisposition to breast cancer." So at first glance, you might think that this patent refers to a diagnostic test for BRCA2, which seems to be an acceptable place for a patent for many people. After all, DNA sequences are just molecules, and there are any number of non-contentious patented tests for biological molecules already- think of glucose test strips, for instance. Manufacturers have found ways to patent various advances in testing for blood glucose without actually asserting a patent on glucose itself.

However, when you test for something like glucose, the test result is going to be a concentration. When you talk about performing a test for BRCA2-based cancer susceptibility, you don't just need to "detect" BRCA2, but be able to isolate it and determine whether it differs from the wild-type BRCA2. So Myriad had the idea that in their patent claims they could define their "methods and materials" to be both the likely molecular bio technique intermediates, and also the molecules that are the theoretical outcomes of any BRCA2 test.

Paraphrasing some of their claims:
-We claim the isolated normal BRCA2 sequence, and any isolated subset of that sequence comprised of at least 15 contiguous nucleotides.
-We claim the isolated major mutant sequence of BRCA2 known to be involved in susceptibility to cancer, and any isolated subset of that sequence comprised of at least 15 contiguous nucleotides.
-We claim nearly 40 different variants of the major mutant sequence.
-We claim any sort of cloning vector, expression vector, recombinant cell line, or PCR primer involving an at least 15 contiguous nucleotide stretch of any of the above sequences.

So Myriad was trying to claim that the invention was a diagnostic method, just that any molecule corresponding to the nucleotide sequences they claimed were an intrinsic part of the "method." What's interesting about the "15 contiguous nucleotides" mention that keeps cropping up is that BRCA2 is over 11000 nucleotides long, producing a protein 3400 amino acids long, such that Myriad laid claim to tiny fragments of the gene which would have had no BRCA2 function on their own.

There is absolutely no way we can grant monopolies on certain aspects of life, to anyone. Whether it is a good business proposal to found science or not, it is not correct at all.

Patents like this come with the power to hold people ransom on existential needs. That cannot, ever, be right.

Another reason, Gene's are nature's "programming language". Once you can read some of it, reasonable efforts will help you to understand more of it.

But, there is no point or fairness in granting anyone who finds out "something" first the right to, for many years, control its use. Things will be found out because people NEED to figure them out, even without prospect to get money from patents. This is also why you don't need to patent software - just because someone needed a selectable button and did it first, that does not mean they should be able to patent it and henceforth control all selectable buttons - someone will absolutely, positively need the exact same thing and would have figured it out themselves anyways, with a reasonable degree of certainty.

The world is filled full of natural examples of how being first gives you a solid distinct advantage.

But the system isn't set up to honor all firsts. The first person to, say, eat an entire bicycle couldn't get a patent on eating bicycles. Finding things doesn't get you patents. You don't patent a new bug discovered, so why should you be able to patent its genetic code?

They are trying to patent a discovered star and charge all astronomers that look at it. The star was there before them. If they used

Do you think that an astronomer should be able to patent a planet because they saw it first? How about the particle physicists working on the LHC patenting the Higgs bosun if they find it (sorry, no gravity without a license!)? Why should someone be able to patent a naturally occurring gene, just because they found it first? If they find something original, such as an easy way to detect the presence or absence of a gene that can lead to illness, or a way to use that knowledge to treat the condition caused by the gene, patent away, but nobody should be able to patent something that has existed in thousands or millions of people for decades or centuries just because they were the first to track it down. They didn't invent or create anything.

And that money that was invested into that research has to pay dividends. And if the knowledge that research provided is locked up in a patent that you can't afford to pay for and you will die because that information ABOUT YOUR BODY is patented. Then you die.

The government and academia are dropping billions of dollars into biotech right now, even with patents. So what's the point?And no. Just identifying a genome and explaining its properties is not patentable. If you discover an hitherto unknown species of beetle and describe it and its ecology you don't get a patent on it either. You just get the right to name it.Currently my body belongs to me (restrictions may apply). If I do something with it, feed it a certain way, train it a certain way, I am free to do

As unpopular as the above statement is on Slashdot and as flawed as the patent system is, it still fulfills purposes making this at least a two sided issue. Ignoring either side is nothing but folly.
You can revise your statement to read: Hopefully it's a net positive for gene research.

Good thought, especially for more tricky examples like patient-derived cell lines or naturally occurring therapeutic molecules, but in this case such worry is not warranted. Treatments, cures, diagnostics, etc are all still patentable, and they are what the investors were looking to make their money from in the first place.

The central issue at stake was whether the discovery of a gene in and of itself, which is just a snipped of biological information, was patentable, and all the resulting technology that utilized that information would be rendered derivative works. Think about that for a moment, if someone went out and discovered a new type of fish, maybe they'd get to name it but they certainly can't claim to own all future profits made by anyone else catching and selling that fish. More to the point, if someone then discovered that the fish produced a chemical that cured some disease, they original discoverer of the fish would not have the ability to sue and say that was reverse engineering of his patented intellectual property. Discovering a gene is not terribly different - it already existed all over the world long before we had to tools to identify and study it. Discovering is different than inventing, and in the case of genes discovery by itself is a far cry from understanding how it works, much less how to manipulate it to fix a disease.

Also, for context, the only real reason one would want to patent a gene is some sort of exclusivity clause (i.e. I discovered this breast cancer gene so now only I can work on a cure for it) or for patent trolling (now lets sue all the other folks working on breast cancer cures). Both scenarios would effectively destroy the ability for competing companies to work on the same disease, and lead to a massive gene-squatting free for all. IAAB (I am a biochemist), and I honestly can't think of any scenarios where being able to patent a naturally occurring gene would be good for either society as a whole or even just letting the market do what it does best.

Also, for context, the only real reason one would want to patent a gene is some sort of exclusivity clause (i.e. I discovered this breast cancer gene so now only I can work on a cure for it) or for patent trolling (now lets sue all the other folks working on breast cancer cures). Both scenarios would effectively destroy the ability for competing companies to work on the same disease, and lead to a massive gene-squatting free for all. IAAB (I am a biochemist), and I honestly can't think of any scenarios where being able to patent a naturally occurring gene would be good for either society as a whole or even just letting the market do what it does best.

I am not a biochemist so I must ask some questions about your particular example with breast cancer genes. I'm lead to believe that 'discovering a breast cancer gene' is extremely difficult. Doesn't the number of sets of DNA one must collect coupled with the accuracy of those collections coupled with the willingness of the volunteers coupled with the number of potential snippets of DNA that could be the gene coupled with all sorts of other complications and permutations make finding such a gene like findi

It's ironic that we can even call this newer thinking "science." The whole point of the scientific method is to allow for peer review and improvement. For centuries, mathematicians and inventors have been building upon one another's work without compensation expectations --they were already schooled and rich enough to be in their advantaged positions. How can Galileo patent finding moons with his telescope, therefore keeping others from legally verifying there is a moon there at all? Now that everyone is ed

I think it's fiarly obvious that exclusive rights to genes, read literally, would be stupid. After all, that would allow the pharmaceutical company to go around suing breast cancer patients for patent infringement on the theory that they probably have the patented genes. If these are not provided for in statute specificaly, I don't think they should be subject to patent.

The closest thing I can think of are plant patents, but they are surprising

The genes can't be patented, because they were discovered, not created, and not discovered in the "OMG I just discovered how to make rubber!" kind of way. They were discovered in the "I just patented New England" kind of way.

Now, the tools and methods of discovery, those certainly should be patentable. The genes were always there, however, and we knew they were there somewhere, and the patent does not allow you to do anything with them, it just tells you where they are.

That is why it was struck down, and that is why this won't have any serious effect on medical research. The stuff that should be patentable is patentable, the stuff that should not be patentable is no longer patentable.

without patents there is no monetary incentive for identifying the function of a gene

If you figure out the function of a gene you can then make a drug to suppress or improve the function of the gene. Or whatever else. And that drug will be, wait for it, patentable! And when that patent comes out and the FDA approves the drug, it's gonna be kinda obvious to people who should know what the drug you're patenting does to what genes and why.

Perhaps what you mean to say is that without patents, when private industry figures out the function of a gene they will keep it to themselves. But that still doesn't make much sense. Unless you're going to take that information and make a treatment out of it, you're not going to be able to monetize it. (And as soon as you make a treatment, you're going to have to explain to the FDA how that treatment works.)

You could, I suppose, make a treatment and not patent it (like a trade secret). But then you're running the extreme risk of having someone else steal/recreate your discovery and patent your medicine out from under you.

Regardless, the motive to research the function of genes is that if you can figure out what a gene does (and it does something useful), you can develop patentable treatments that manipulate that gene. Patenting the gene is just the icing on the cake.

But you don't need to research the function of the gene to develop a patentable treatment, so long as you know the guy down the street is going to research the function and let everyone know.

For instance, Myriad made their money by sequencing BRCA genes - but they only sequence BRCA because they figured out the function of the genes in breast cancer risk. The first part (sequencing tests) is easy, I can quite literally design a sequencing test for that tomorrow (I am a molecular geneticist), but figuring

If you patented a breathalyzer, would you call it a patent on alcohol?

No, but if the patent was written such that any test that detected alcohol would violate the patent, then it would be a patent on alcohol. That's my understanding of Myriad's patent and assertions about it. There is simply no way to create another test for BRCA2-based cancer that does not violate the patent, using any method. That's why the patent is broken and should be thrown out.

FTFA: "The patents granted to Myriad give the company the exclusive right to perform diagnostic tests on the BRCA1 and

Then you need to learn some math. Lower drug prices is a WIN for customers. No patents
to prevent public research breakthroughs is a WIN for science. That's two WINs, count'em.

If companies can't get a patent, why would they
invest millions, even billions, into the research, if the moment they make a
discovery, the company next door gets to profit from their research for free
with ZERO seed investment.

For the same reason companies today invest millions, even billions into contributing
to open source, like the Linux kernel, even though their competitors get to
profit from those contributions for free with ZERO seed investment.

What this DOES do is essentially put all genetics research companies out of
business,

Good riddance to bad rubbish. If the only way they can contribute research is
by blocking others with patents, then we don't need their "research".

and leaves it to government organizations and government funded
educational institutions to do the research.

That's a good idea. Medical breakthroughs should be available to all citizens
unencumbered by patents, and at affordable prices, and that's the best way
to ensure this in the long term. Some industries, like health care, are strategically
important. Moreover, with fewer private companies to drain the smart people from
universities, the next generation of students would have a higher quality education.
Yet another WIN.

Medical breakthroughs should be available to all citizens unencumbered by patents, and at affordable prices, and that's the best way to ensure this in the long term.

You have missed my point entirely. Without massive private funding these "medical breakthroughs" (which I'm led to believe are needle-in-haystack searches) happen at a slower rate. If that sets it back more than the length of a patent (which is 20 years in the US) then it's a negative net effect on the genetic cures we find for people.

You'll have more affordable cures for the first 20 years but after that the prices will be the same. The difference could be the number of cures and their quality.

Conversely if you take the money that goes to fat upper management. massive marketing departments, and stockholder profits and plow it back into research you probably end up with more cures. The free market isn't always the most efficient way of accomplishing things despite what some of its adherents like to think.

you sell less drugs, and there's less money for R&D. Pharma doesn't spend money on marketing unless it generates more revenue than it costs: they have the guys with calculators to figure that out. Spending money on buying back shares, private jets, or buying out Sirtris: yeah, that hurts R&D. Marketing the drugs to people who shouldn't be taking them (Vioxx) and then losing 3x as much in the inevitable lawsuits: yeah, that hurts R&D. Someone did a study a while back, and found that the biggest

And I'm sure the person(s) doing that study had NO connection or expected future connection to the pharmaceutical industry.... Oh and the goal shouldn't be to sell more drugs, it should be to do the maximum amount of good with the available resources. I'm sure a robocaller reminding people to pickup their already refilled prescription would be a hell of a lot cheaper than the marketing arm of big pharma.

But the fact still remains, any treatment, drug, etc., based upon the gene's discovery, is as patentable as it ever was. The only thing you can't patent is the gene itself, and that's quite correct. If you discover a certain isotope, and find a way to make workable fusion energy from it, you can patent your reactor, but not the isotope itself. That's exactly how the patent system is meant to work-you can patent things you invent, but not things you just find.

That being said, it always saddens me to see "capitalism" thrown around like it's some unimpeachable, unquestionable good force. I wish people would question it, as it's sure got an awful lot of negatives. At some point, I sure hope we can find a better system.

While I agree the patent system needs work, being so one-sided may be a bit too far. I support the use of government money to fund medical research (the saving lives kind, not the blue pill kind), but there is only so much money out there. Unlike copyrights, medical patents do expire, so these corporate-funded breakthroughs benefit everyone in the end (of course, Big Pharma wants to change this).

The government only has so much money to put into research, so it should be focused on things that take longes

Patents aren't perfect. No form of IP is - all forms of IP are a compromise.

But in large part, (perhaps excepting software patents and MAYBE gene patents) the concept of a "patent" gets it RIGHT!!!

In the area of pharmaceuticals, If you do away with patents, then you lose the endless supply of 20-year-old innovation you now know as "generic drugs" because the deal with patents is that, in exchange for FULL AND COMPLETE DISCLOSURE of the patented concept, the owner/holder of the patent gets a reasonable amoun

Come on, if God was such a freaking fantastic engineer, why the hell did he put a sewage outlet right in the middle of a recreational zone?

A recent (non-scientific) sampling I made of the cultural practices depicted in a certain category of popular films would suggest that for many, both are recreational and the placement is considered a feature. Then, of course, there's the Germans.

As for the article, if you think patenting genes is outrageous, consider the patenting of turmeric [wikipedia.org].

Attacking lawyers completely misses the point. You should be attacking the greedy medical researchers and doctors who decided to patent a gene. Lawyers are just middlemen. If the doctor-inventors weren't greedy SOBSs, they wouldn't have patented the genes to they could extort a higher amount from women trying to not die of breast cancer.

Yes, and Monsanto employees and representatives should attempt to avoid walking on the target range of farmers accused of innocent infringement, though I think it would improve the world if they couldn't help themselves but to sit on target ranges more often. Our very own former Vice President set a precedent for the accidental shooting of people in hunting parties and on target ranges. In case the FBI is listening, I'm not advocating that people shoot at Monsanto employees and lawyers. Indeed, I think thos

But I'm kind of upset that we live in a society that we have to tell someone "No, you cannot have exclusive rights to a natural occurrence." Worse yet, this "patent" prevented anyone from even looking at the gene, whether it was for diagnostic or research purposes.

You can't patent coal, or wood, so why should you be able to patent a natural resource like DNA? If they create something new from it, like a new allele or treatment, I'd say that's fair game.
In the end, this is an extremely important ruling, but unfortunately it's probably not the end. It will probably require the Supreme Court to make a ruling. I don't see anyone involved giving up that easily.

Even for a new allele, say a SNP, its combination is only A, C, T, or G. Unless they can show that it is highly unlikely that the patented modification would occur naturally, any new alleles should be patent free. And heck, they can't compare the chance with pure random chance since we know that mutations / gene modifications do not occur randomly either. Claiming so would be very hard.

New treatment may or may not be patentable as well. If the treatment involves a naturally occurring sequence from other peo

Certainly the treatment, even if its naturally occurring, would still be patentable. Sure, they wouldn't likely be able to win a lawsuit against a guy whose body was producing their treatment (ala Monsanto), but they could definitely win against another pharma producing and selling their patented treatment in vats. Which is what they want the patent for anyways.

The allele thing is probably similar. They could still patent the assembly of the pieces in

Back in my day, genes were supposed to help give you the rugged looks of a cowboy or an outdoorsman, not of a greasy 19-year old kid on the make at the disco with his obnoxious friends. Patent genes! What will they think of next!!

Hopefully this will go a long way in ensuring that patents on genes do not stand in the way of research.

If you look at the empirical data [umd.edu], gene patents don't interfere with research. In a survey of 414 biomedical researchers at universities, government, and nonprofit institutions, none of the 381 respondents reported abandoning a line of research due to patents and only five delayed completion of an experiment for more than one month. Only one respondent reported paying for access to research materials co

Only one respondent reported paying for access to research materials covered by a patent

sounds to me like 1 out of 381 research labs were using patented genes. either the patented genes aren't all that interesting (possible) or the researchers are actively choosing not to research those genes to avoid the patent issues.

Well, I suppose it's nice that someone finally ruled you can't patent the genetic code itself, but the net change will be practically nothing.

If they can still patent every single technique and tool involved in examining, testing, or isolating the gene then who gives a crap if they pretend they own the code? We'll still end up reinventing the wheel every time we'd like to look at any known gene; either that or we'll pay thousands of dollars in patent fees per procedure. I suppose it's nice that some distr

It was so surreal to see this as the most recent headline on Slashdot - two minutes before, I'd finished listening to the audio version of "The Immortal Life of Henrietta Lacks," which touches on issues surrounding genetic research and the unfortunate incursion of capitalism into tissue storage and research. The book itself is a fascinating mix of science and history, but the Afterword is all about the commercialism of genetic research and the obstacles it's introducing to scientific progress. Who owns hu

Patents, even of genes, may not be a bad thing. Here's the point of patents: you have to reveal how it works. Why? to advance the state of the science. Not to create a monopoly, but rather to prevent them. I know this is counter intuitive. But it creates a a situation where the next research group can come along, study the patent and then say "Aha! Now we know the next step to take". And as long as they can show a substantial improvement, they can patent their work as well, even *before* the previous patent

It occurred to me that capturing genetic code as a database is somewhat (albeit remotely) like taking a photograph of something that already exists in nature.
If patents are there to protect invention (ie, to encourage invention by making it profitable), why is literary work not patentable? If a sci-fi writer invents a new scientific concept and builds a story around it, he may be able to patent that scientific concept, but there's nothing to stop other writers from stealing his invention in writing, is th

I think your basic idea goes too far, but in this, at least, I agree. All business patents should be thrown out on the grounds that patents were never intended to protect ideas, just concrete applications of them. And, on the grounds that patent law originally specified that methods in and of themselves were not patentable, out go the software patents along with the rest. Do that, and most of the mess clears itself up.

But then all the lawyers would resubmit millions of applications every year. You also have to limit the number of submissions per inventor or apply a tiered pricing program (first three applications cost $200 each, next 10 cost $10,000 each, after that $30,000 each). That way small inventors could compete with large corporations without totally swamping the system.

Yes! And there should be several rounds of competition and public voting! The competitors must complete several challenges during each round, such as digging for prior art to disqualify their rivals and giving speeches to defend their claim to the Top 10. The whole thing should be shown on C-SPAN and hosted by a three-judge panel: a patent lawyer, an inventor, and Paula Abdul.

Both, which is sort of what the whole case was about. Just looking at 5747282 for example, the majority of the claims are for a specified sequence, then look at claim 20:

20. A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of gro

The glib answer I'm about to give makes it seem clear-cut, but it really isn't.

Punitive sentences for the unrepentant, rehabilitative for those who are misguided or simply mentally ill.

The problem is, how do you tell when a convict is one or the other? Quasifunctional sociopaths are accomplished, convincing liars (they even convince themselves, sometimes) and could act like they're all cured. The mentally ill, once rehabilitated, might be overwhelmed by guilt and retreat into the 'easy' path of seeking pu